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NCT Number: NCT03135340

Wide-Awake Local Anesthesia vs. Regional/General Anesthesia for Flexor Tendon Repair

Wide-awake hand surgery with local anesthetic, no tourniquet and no sedation (WALANT) is increasingly utilized. Conventional anesthesia for hand surgery involves a patient with a block, unable to perform motor function in the arm, and with patient either intubated or sedated, unable to follow surgeon instructions intra-operatively. Flexor tendon repair with a wide awake and cooperative patient is routinely performed successfully at some centres. This method provides several potential benefits including being able to have the patient actively flex the digit and visualize the repair site to assess for any tendon gapping at the repair site, ensure adequate approximation, gliding and absence of triggering. There have not been any prospectively collected randomized controlled trials comparing wide awake vs. regional/general anesthesia in flexor tendon repair. The purpose of our study is to assess for differences in early outcomes including stiffness, patient satisfaction and early complications in wide-awake anesthesia when compared to general/regional anesthesia for flexor tendon repair in zones I and II. Our hypothesis is that there is a lower complication rate and better outcomes when using wide-awake flexor tendon repair.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Primary repair for flexor tendon lacerations remain the standard of care. However, despite recent advances in knowledge of tendon healing, suture material, and post-operative protocols, outcomes have been reported as fair or poor in 7-20% of patients. Complications encountered include adhesion formation, development of joint contractures, tendon rupture, triggering, bowstringing and quadrigia.

Wide-awake flexor tendon repair using local anesthesia and epinephrine with no tourniquet has been described. Safety of epinephrine in digits makes it possible, and epinephrine-induced vasoconstriction precludes the need for a tourniquet and cautery.This approach allows a wide-awake, comfortable, non-sedated, cooperative, tourniquet-free patient to test the freshly repaired tendon with full active range of motion intraoperatively. The surgeon can inspect for bunching, gapping, and triggering of the repair site in an active fashion. Thus, an opportunity is available to revise the repair, trim or add extra sutures, revise pulley reconstruction, or de-bulk tendons before wound closure. This could mean that a higher quality repair is possible and could guide post-operative rehabilitation. It follows that if the patient is unable to achieve total active range of motion intraoperatively they will not be able to postoperatively and may end up requiring a tenolysis. Lalonde and colleagues looked retrospectively at their 15 years of experience using WALANT with the hypothesis that this technique decreased their post-operative rupture rate. With 122 patients there were only 3 ruptures, all due to unexpected forceful movements. Contraindications of this technique include patients who are unable or unwilling to tolerate an operation while awake, pediatric patients, those who are mentally impaired, and complex trauma.

Improved compliance with postoperative therapy is also reported after patients visualize the repair in real time and gain a better understanding of limitations and expectations. Patient buy-in to the rehabilitation process is potentially improved if the surgeon can use the operative time to educate the patient, show them the repair, and manage expectations since the patient is wide-awake and coherent. Wide-awake flexor tendon repair could also improve surgeon confidence in initiating a true active motion therapy protocol when the surgeon visualizes the absence of gapping with full finger flexion. Initiation of early active motion could subsequently improve ultimate post-operative range of motion and patient satisfaction. The advent of wide-awake flexor tendon repair could have economic implications as well given that fewer resources are theoretically used for the procedure.

Currently there are no prospective randomized controlled studies evaluating outcomes in flexor tendon repairs that have utilized a wide-awake anaesthesia protocol and comparing outcomes with traditional repair techniques.

The purpose of this study is to evaluate and compare outcomes of WALANT (wide-awake, local anesthetic, no tourniquet) when compared to traditional general/regional anesthetic for flexor tendon repairs in zone I and II.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • over the age of 18
  • acute single or multiple digit complete flexor tendon lacerations in zones I or II presenting to attending physicians who agree to participate in the study.

Exclusion criteria

  • gross wound contamination
  • segmental tendon loss
  • associated finger fractures
  • sub-acute or chronic ruptures (ruptures > 6 weeks old)
  • active or previous infection in the wound bed
  • requirement of delayed repair
  • complex or multisystem injuries
  • multiple digit injuries
  • significant joint injuries
  • amputations (replants)
  • mangled hand injuries.

Treatment and study plan

WALANT

Procedure

These patients will receive local anesthetic for flexor tendon repair injected directly into the operative site on the hand. The local anesthetic used 1% lidocaine with 1:100,000 epinephrine.

General/regional anesthesia

Procedure

These patients will receive general/regional anesthesia for flexor tendon repair. This is ropivacaine 0.5% injected by an anesthetist under image-guidance in the axillary region of the arm. If the regional anesthesia is not functioning at the time of OR, this is converted to a general anesthetic as per standard protocol.

WALANT Injection

Drug

1% lidocaine with 1:100,000 epinephrine injected directly into operative site. The typical quantity is 5-10cc aliquots.

Regional Anesthetic Injection

Drug

0.5% ropivacaine injected under ultrasound guidance into the axilla. The typical quantity is 30-40cc aliquots.

Primary outcomes

  1. Complication rate

    Time frame: 1 year

    Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis

Secondary outcomes

  1. Total active range of motion

    Time frame: 1 year

    This is measured as active digit motion measured at the proximal interphalangeal and distal interphalangeal joints with use of a goniometer by a hand therapist

  2. Strickland Criteria Score

    Time frame: 1 year

    The sum of active ranges of motion of the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints. Then the percentage is calculated, in comparison to the contralateral side. The scores are then recorded as one of four categories: Excellent: 85-100%, Good: 70-84%, Fair: 50-69, Poor: 0-49%

  3. Pain of procedure by visual analogue scale (VAS)

    Time frame: 1 week

    Measured on visual analogue scale on a 10cm line and scored out of 10 (0 being no pain and 10 being maximum pain)

  4. Pain of procedure by pain diary

    Time frame: 1 week

    The pain diary is used by the patient at home to record subjective daily pain from 0-10 at a predetermined time every day.

  5. Subjective anxiety

    Time frame: 1 week

    anxiety surrounding procedure as measured on a VAS (from 0 being no anxiety to 10 being maximum anxiety)

  6. Repeat procedure question

    Time frame: 1 week

    The patient is asked whether or not they would undergo the procedure the same way again (yes or no).

  7. DASH (disabilities of the arm, shoulder and hand) Score

    Time frame: 1 year

    This outcome instrument is a thirty-question self-reported survey of function and symptoms in patients with upper extremity disorders. Scores range from 0 (no disability) to 100 (completely disabled).

Study contacts

Contact information is provided by the study sponsor or research team.

Ruby Grewal, MD MSc FRCSC

CONTACT

[email protected]

519-646-6286

Tym Frank, MD, FRCSC

CONTACT

[email protected]

778-870-5772

Sponsors and collaborators

Lead sponsor

University of Western Ontario, Canada

Other

Registry information

Official study title

Comparison of Wide-Awake Local Anesthesia vs. Regional/General Anesthesia for Hand Flexor Tendon Repair in Zones I and II: a Prospective Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2033
First posted
May 1, 2017
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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